FDA 510(k)

RADIONUCLIDE BRACHYTHERAPY SOURCE

K-Number: K093663 · 2009-12-23

Decision Date2009-12-23

Product CodeKXK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RADIONUCLIDE BRACHYTHERAPY SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K093663. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONUCLIDE BRACHYTHERAPY SOURCE?

RADIONUCLIDE BRACHYTHERAPY SOURCE is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K093663.

When did RADIONUCLIDE BRACHYTHERAPY SOURCE receive FDA 510(k) clearance?

RADIONUCLIDE BRACHYTHERAPY SOURCE received FDA 510(k) clearance on 2009-12-23, under 510(k) number K093663.

Who is the listed applicant for RADIONUCLIDE BRACHYTHERAPY SOURCE?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIONUCLIDE BRACHYTHERAPY SOURCE?

The FDA product code for RADIONUCLIDE BRACHYTHERAPY SOURCE is KXK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.